Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-30 @ 5:29 AM
Study NCT ID:
NCT04328506
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2020-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalency Study of CM082 Tablet in Healthy Volunteers
Sponsor:
AnewPharma
Organization:
Study Overview
Official Title:
Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of CM082 Tablet in Healthy Chinese Volunteers Under Fasted State and After Meal
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers.
Detailed Description:
The main objective of this study is to evaluate the bioequivalency of two preparations of CM082 tablet in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of CM082 tablet in Chinese healthy volunteers will also be evaluated.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: